250 mg and 500 mg film-coated tablets respectively
valaciclovir
What Valaciclovir Actavis is and what it is used for
Valaciclovir Actavis belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses called herpes simplex ( HSV ), varicella zoster ( VZV ), and cytomegalovirus ( CMV ).
Valaciclovir Actavis can be used to:
- treat shingles (in adults)
- treat HSV skin infections and genital herpes (in adults and adolescents over 12 years of age). It is also used to help prevent these infections from coming back.
- treat mouth ulcers (in adults and adolescents over 12 years of age)
- prevent CMV – infection after organ transplantation (in adults and adolescents over 12 years)
- treat and prevent HSV – eye infection that keeps coming back (in adults and adolescents over 12 years of age).
The valaciclovir contained in Valaciclovir Actavis may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Valaciclovir Actavis
Do not take Valaciclovir Actavis
- if you are allergic to valaciclovir or aciclovir, or any of the other ingredients of this medicine (listed in section 6).
- if you have ever developed a widespread rash associated with fever, enlarged lymph nodes, increased levels of liver enzymes, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.
Do not take Valaciclovir Actavis if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valaciclovir Actavis.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valaciclovir Actavis:
- if you have problems with your kidneys
- if you have liver problems
- if you are older than 65 years
- if your immune system is weak.
If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking Valaciclovir Actavis.
Take special care with Valaciclovir Actavis – important information:
Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with the use of valaciclovir. DRESS presents initially as flu-like symptoms and with a rash on the face then a widespread rash and high body temperature increased levels of liver enzymes seen in blood tests, and an increase in a type of white blood cell ( eosinophilia ) and enlarged lymph nodes.
If you develop a rash associated with fever and enlarged lymph nodes, stop taking valaciclovir and contact your doctor or seek medical attention immediately.
Prevent transmission of genital herpes to others
If you are taking Valaciclovir Actavis to treat or prevent genital herpes, or if you have previously had genital herpes, you should still practice safe sex, which means using a condom. It is important to prevent you from infecting others. You should not have sex if you have genital sores or blisters.
Other medicines and Valaciclovir Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might be taking other medicines, including over-the-counter medicines, herbal medicines, or other natural products.
Tell your doctor or pharmacist if you are taking other medicines that affect the kidneys. These include aminoglycoside, organoplatinum compounds, iodinated contrast agents, methotrexate, pentamidine, foscarnet, cyclosporine, tacrolimus, cimetidine, and probenecid.
Always tell your doctor or pharmacist if you are taking other medicines while taking Valaciclovir Actavis for the treatment of shingles or after an organ transplant.
Pregnancy and breastfeeding
Valaciclovir Actavis is not normally recommended for use during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, do not take Valaciclovir Actavis without consulting your doctor or pharmacist. Your doctor will then consider the benefit to you against the risk to your baby of taking Valaciclovir Actavis while you are pregnant or breastfeeding.
Driving ability and use of machinery
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Valaciclovir Actavis can have side effects that can affect your ability to drive.
Avoid driving or operating machinery unless you are sure you are unaffected.
How to take Valaciclovir Actavis
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The doctor determines the dose according to the reason for your treatment. Your doctor should discuss this with you.
Treatment of shingles
- The usual dose is 1000 mg (two 500 mg tablets) three times daily.
- You must take Valaciclovir Actavis for seven days.
Treatment of mouth ulcers
- The usual dose is 2000 mg (four 500 mg tablets) twice daily.
- The second dose should be taken 12 hours (not earlier than 6 hours) after the first dose.
- You must take Valaciclovir Actavis for only one day (two doses ).
Treatment of HSV skin infections or genital herpes
- The usual dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice daily.
- For the first infection, you must take Valaciclovir Actavis for five days, or up to ten days if your doctor has prescribed this. In case of recurrent infection, the treatment period is normally 3-5 days.
To help prevent HSV infections from coming back after you’ve had them
- The usual dose is one 500 mg tablet once daily.
- Some patients with frequent recurrent infections may benefit from taking one 250 mg tablet twice daily.
- You should take Valaciclovir Actavis until your doctor tells you to stop.
To prevent you from becoming infected with CMV ( Cytomegalovirus )
- The usual dose is 2000 mg (four 500 mg tablets) four times daily.
- You should have an interval of 6 hours between each dose.
- You should take Valaciclovir Actavis as soon as possible after your operation.
- You should take Valaciclovir Actavis for about 3 months after your operation until your doctor prescribes you to stop.
Your doctor may adjust your dose of Valaciclovir Actavis:
- if you are older than 65 years
- if you have a weak immune system
- if you have kidney problems.
→ Talk to your doctor before taking Valaciclovir Actavis if any of the above applies to you.
Take this medicine
- Take this medicine by mouth.
- Swallow the tablets whole with water.
- Take Valaciclovir Actavis at the same time each day.
- Take Valaciclovir Actavis as directed by your doctor or pharmacist.
People older than 65 or people with kidney problems
While you are taking Valaciclovir Actavis, you must drink water regularly throughout the day. This can help reduce the side effects that can affect the kidneys or nervous system. Your doctor will check if you show any signs of this. Side effects from the nervous system can be that you feel confused, agitated, unusually sleepy, or drowsy.
Children under 12 years of age
Valaciclovir Actavis is not recommended for children under 12 years of age.
If you have taken too much Valaciclovir Actavis
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Valaciclovir Actavis is usually not harmful if you do not use it too much for several days in a row. If you take too many tablets, you may feel sick, vomit, have kidney problems, become confused, and agitated, experience altered consciousness, see things that are not there or pass out. Talk to your doctor or pharmacist if you have taken too much Valaciclovir Actavis. Take the medicine package with you.
If you forget to take Valaciclovir Actavis
- If you forget to take Valaciclovir Actavis, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
- Do not take a double dose to make up for a missed dose.
If you have any further questions regarding the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions you need to be aware of:
Stop using Valaciclovir Actavis and see a doctor immediately if you experience any of the following symptoms:
Severe allergic reactions ( anaphylaxis ). These are rare in those taking Valaciclovir Actavis. The rapid development of symptoms such as:
- redness, itchy rash
- swelling of the lips, face, neck, and throat, causing difficulty breathing ( angioedema )
- drop in blood pressure leading to collapse.
Skin rash or redness. Skin side effects can appear as a rash with or without blisters. Skin irritation, edema (DRES’s syndrome), fever, and flu-like symptoms may occur.
The following side effects can also occur with this medicine:
Very common (may affect more than 1 in 10 users):
- headache
Common (may affect up to 1 in 10 users):
- nausea
- dizziness
- vomiting
- diarrhea
- skin reactions after exposure to sunlight ( photosensitivity )
- rash.
- itching ( pruritus ).
Uncommon (may affect up to 1 in 100 users):
- confusion
- hallucinations (seeing or hearing things that aren’t there)
- drowsiness
- tremor _
- the feeling of outrage.
These side effects from the nervous system usually occur in people with kidney problems, in the elderly, or in organ transplant patients who take high doses of Valaciclovir Actavis, ie 8 g or more per day. It usually gets better when Valaciclovir Actavis is stopped or when the dose is reduced.
Other less common side effects:
- shortness of breath ( dyspnea )
- stomach upset
- skin rash, sometimes itchy, hives ( urticaria )
- low back pain (kidney pain).
- blood in the urine ( hematuria ).
Less common side effects that can be detected in blood tests:
- decrease in the number of white blood cells ( leukopenia )
- decrease in the number of platelets, which help the blood clot ( thrombocytopenia )
- increase in substances produced by the liver.
Rare (may affect up to 1 in 1,000 users)
- unsteady gait or lack of coordination ( ataxia )
- slow and slurred speech (dysarthria)
- seizures (convulsions)
- altered brain function ( encephalopathy )
- unconsciousness ( coma )
- confused or disturbed thoughts ( delirium )
These side effects from the nervous system usually occur in people with kidney problems, in the elderly, or in organ transplant patients who take high doses of Valaciclovir Actavis, ie 8 g or more per day. It usually gets better when Valaciclovir Actavis is stopped or when the dose is reduced.
Other rare side effects:
- kidney problems, which manifest themselves as urinating little or no urine.
Frequency not known (cannot be estimated from available data)
- drug reaction with eosinophilia and systemic symptoms also known as DRESS or drug hypersensitivity syndrome, characterized by a widespread rash, high body temperature, elevated liver enzymes, blood abnormalities ( eosinophilia ), enlarged lymph nodes, and possible effects on other organs. See also section 2.
How to store Valaciclovir Actavis
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the carton. The expiration date (Exp) is the last day of the specified month.
- Store at a maximum of 30 °C.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is valaciclovir. One tablet contains 250 mg or 500 mg of valaciclovir (as valaciclovir hydrochloride monohydrate).
Other ingredients are:
Tablet core:
Microcrystalline cellulose
Povidone
Magnesium stearate
Film coating (paddy white Y-5-7068)
Hypromellose
Hydroxypropyl cellulose
Titanium dioxide (E171)
Appearance and package sizes of the medicine
Valaciclovir Actavis are oval, white, biconvex, and film-coated tablets with the following label:
250 mg tablets: 13.8 x 6.9 mm debossed with VC1 on one side.
500 mg tablets: 17.6 x 8.8 mm debossed with VC2 on one side.
PVC/aluminium blister.
Pack sizes (blisters): 10, 20, 21, 24, 30, 42, 60, 90 film-coated tablets.
HDPE cans with closable LDPE lid.
Pack sizes (cans): 10, 30, 100, 250 film-coated tablets.
Not all pack sizes may be marketed.
Actavis Group PTC ehf.
Reykjavikurvegi 76-78
IS-220 Hafnarfjordur
Iceland